Wednesday, December 22, 2010

Bottom Ten Worst Prescription Drug/Medical Device Decisions Of 2010

We’re doing it again. At the end of the year, we like to look back over where we’ve been for the past twelve months. As always, that long and winding road had a few bumps along the way. It’s the jarringness of those bumps that we’re rating today. That’s right, just as we’ve done for the past three years, we’re rating the ten worst prescription medical product liability decisions of 2010. These lumps of coal in our stocking come from all over – from federal and state courts, from hellhole jurisdictions and from hellhole wannabes.

Sure, there’s a week and a half left for the other side to play “Can You Top This,” and a bad Supreme Court decision to finish off the year could throw everything that follows into a cocked hat, but that’s life in the blogosphere. We always reserve the last week of the year for something more fun, specifically celebrating the top ten best decisions.

But to get to the best, we have to get through the worst. So let’s get it over with – here are the ten bumpiest bumps in the road, or lumpiest lumps in our stockings – our bottom ten worst judicial drug and device decisions of 2010.

1. Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010). In the wake of Wyeth v. Levine, 129 S. Ct. 1187 (2009) (last year’s #1 worst), we've endured a lot of bad preemption decisions in prescription drug cases. Some we pretty much expected. Some we didn’t. Wimbush is one we didn’t, because the claim in question wasn’t anything resembling the warning claim that the Supreme Court said it was reviewing in Levine. Instead, Wimbush (known as “Longs” in the district court) involved – and we quote – “claims that [the defendant] was negligent for bringing [the drug] to market at all.” 619 F.3d at 641. In other words, the claims at issue had nothing to do with warnings, and everything to do with a direct challenge to the FDA’s decision to approve a drug in the first instance. That wasn’t Levine. If anything, those claims were closer to the claim of “duty to contraindicate” an FDA approved drug use that the Levine Court specifically stated it wasn’t deciding (presumably because it couldn’t muster an anti-preemption majority). 129 S. Ct. at 1194. In a decision that permits a direct conflict between a state law claim (you should never have sold the product at all) and the FDA approval that was in force at the time of the plaintiff’s prescription, Wimbush folded, spindled, and mutilated both Levine and the FDA, holding that there was no preemption even in a raw conflict (yes vs. no) situation. 619 F.3d at 644-45. All we can do now is hope that the Supreme Court grants review of the inevitable certiorari petition, as the Sixth Circuit denied en banc review on October 14, 2010. We've previously decried Wimbush in greater detail here.

2. Wyeth v. Rowatt, ___ P.3d ___, 2010 WL 4812919 (Nev. Nov. 14, 2010). As we mentioned before, we’re limited on what we can say about the substance of Rowatt because we do hormone therapy defense, too. Rowatt takes #2 because it’s an extremely adverse decision by a state supreme court. It’s not so much the issues that the opinion decided, although they’re bad enough (especially the holding that a defendant can be liable for punitive damages despite complete compliance with the FDA’s detailed regulatory scheme, id. at *13-14), but the sheer amount of error that was waved off in order to affirm a huge (almost $58 million) verdict. There are at least four places where the Rowatt court found that the trial court erred (improper causation instruction, id. at *11-12; misleading life expectancy instruction, id. at *13 n.9; inflammatory closing argument, id. at *17 n.11; the jury deliberating, and awarding, punitive damages, in the compensatory phase of trial, without any instructions from the trial court, id. at *15, 20-21). Didn’t matter; all harmless. That last point, the runaway jury awarding punitive damages on its own volition, particularly troubles us, because in Phillip Morris USA v. Williams, 549 U.S. 346, 357 (2007), the Court held that proper jury instructions concerning “third party injury” evidence are constitutionally required. For a jury to decide punitive damages without any instructions at all (regardless of then returning almost identical numbers during a do-over), seems to us to be a per se violation of Williams. This is another case where a certiorari petition is now the defendant’s only hope. Following the adage that, if you can’t say anything nice (and are prevented from doing the opposite), don’t say anything at all, we haven’t blogged before about Rowatt.

3. Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010). Another truly awful prescription drug preemption decision in the wake of Wyeth v. Levine. It’s not quite as bad as Wimbush because at least Mason involved a warning claim. But it’s still pretty bad because Mason was the first post-Levine appellate decision involving SSRIs and suicidality – an issue that the FDA looked at many times and (as to adults, anyway) has always concluded that the scientific evidence was insufficient to warrant the warning the plaintiffs demanded. In fact, these SSRI cases were what bothered the FDA (back when Clinton was president) enough that it got involved with the preemption issue to start with. It’s not just losing preemption in Mason that bothers us (although that does sting), but the intellectual dishonesty of the decision. To rule against preemption, Mason took the result in Levine and then added to it the Levine facts as found by the Levine dissent, which of course considered those same facts to weigh favor of preemption. 596 F.3d 392-93. Only by thus creating a legal chimera, could the decision hold that the outcome of nearly a decade of FDA review of the precise risk at issue wasn’t preemptive. We made these points (and more) about Masonhere.

4. Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010). The most pro-plaintiff court of appeals (so we’ve been told) in Texas reached way out to hold that Texas would become the second state in the country (after New Jersey over a decade ago) to recognize a blanket exception to the learned intermediary rule for direct-to-consumer advertising. Id. at 504-07. The decision is a reach, first, because every other Texas case to consider a DTC exception (admittedly not a whole bunch) had trampled it underfoot. But Hamilton is even more of a stretch because … it’s not even a DTC advertising case. The allegedly inadequate material was sent to doctors – not patients. Id. at 486 (plaintiff only received video after the prescription had “already been made”). There was no non-physician-mediated contact at all between the plaintiff and the defendant manufacturer. Hamilton lunged for the DTC exception because all the doctors treating the plaintiff were well aware of the risk at issue, id. at 483-86, so something new was necessary to side-stepp prescriber knowledge that would otherwise be fatal to a nearly $5 million verdict. We pointed out these flaws in Hamiltonhere, and we’re pleased to note that, as of this writing, it appears likely that the Texas Supreme Court will hear a further appeal.

5. In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334 (N.D. Ohio May 4, 2010). We’ve already described this error-fest here. To recap, the decision: (1) applied radically different degrees of scrutiny to expert opinions, depending on which side offered them, compareid. at *6-7, *18-19, *22-23, with, id. at *26-31; (2) allowed plaintiff’s experts to discount “unknown” causation mechanisms, id. at *3-4; (3) let in a variety of junk science (in vitro, in vivo, etc.) when the plaintiffs offer it, id. at *7; (4) allowed use of ADEs as evidence of causation, despite the FDA saying they’re useless for this purpose, id. at *9-11; (5) let plaintiffs’ experts offer legal opinions, particularly about preempted fraud on the FDA issues, id. at *11-17; (6) allowed testimony about foreign regulatory actions under different administrative schemes; id. at *17; and (7) precludes defense witnesses from offer legal opinions opposed to the plaintiff’s experts because the court disagrees with them on the merits. Id. at *30-31. To top it off, despite a second chance to reconsider its rulings – the court instead kept digging. See 2010 U.S. Dist. Lexis 122797 (N.D. Ohio June 18, 2010) (denying reconsideration). We called it “spherical error” then. We call it #5 now.

6. Lance v. Wyeth, 4 A.3d 160 (Pa. Super. 2010). We’ve become involved in this case since the Superior Court decided it, so once again we find we’re limited in what we can say. Lance is another example of the disturbing trend in post-Levine cases for plaintiffs to push for – and, worse, for courts to allow – “design” related claims against prescription drugs that are really frontal assaults on FDA drug approval decisions. Here, the claim was “negligent design,” which had never before been recognized in a prescription drug product liability case in Pennsylvania. 4 A.3d at 165-66. Disturbingly, the opinion does not discuss the requirement, imposed in negligent design cases involving other products, that the plaintiff must prove the existence of a safer alternative design. Compounding matters, Lance also included gratuitous dictum suggesting that a post-sale duty to warn may exist in prescription drug cases, id. at 167-68 – despite that theory being a form of strict liability, which Pennsylvania doesn’t recognize at all in prescription medical product litigation. If not for other, favorable, aspects of Lance (rejecting the “unreasonably dangerous product theory allowed in Wimbush and also failure to test or to recall), Lance might rank even higher/lower. We discussed Lancehere. An appeal to the Pennsylvania Supreme Court is pending.

7. In re Fosamax Products Liability Litigation (Boles), 2010 WL 3955814 (S.D.N.Y. Oct. 4, 2010). By the numbers: (1) The first trial ended in a hung jury. (2) On retrial the plaintiff’s counsel “antics,” were (in the words of the judge) “outrageous,” and “unprofessional.” Id. at *14-16. (3) Plaintiff’s closing included “a roundabout attempt to put the issue of punitive damages [which had been dismissed] before the jury.” Id. at *18. (4) The jury then returned a multimillion dollar verdict – considerably larger than even plaintiff had requested. Id. Then, that verdict is … sustained? Id. at *17-18. Unbelievable. For this reason alone Boles would warrant consideration for our bottom ten. We’re sorry, but no remittitur can cure a verdict created in this fashion. But Boles is even worse. It’s yet another example of the post-Levine plaintiffs’ frontal assault on FDA drug approvals, as the prevailing theory was that the drug “is unreasonably dangerous in that its risks outweigh its benefits.” Id. at *6. The opinion found the jury’s rebalancing of the FDA’s risk/benefit determination not preempted. Id. at *10-11. Just to permit this claim under state (Florida) law, the decision cast aside both a section of the Third Restatement and a state statutory presumption of product adequacy from FDA compliance. Id. at *7-8. The decision then held that the risk in question (never before mentioned in the scientific literature at the time of plaintiff’s use) was “foreseeable” by piling rubbish (anecdotal ADEs that didn’t mention the risk either) atop junk science (animal studies). Id. at *9-10. We blogged about this peculiar result here and here.

8. Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2765358 (D.N.H. July 12, 2010). As in Lance, there are other rulings in this decision that keep it from being a total downer, meaning that it doesn’t rank higher on our list. What puts our teeth on edge is, once again, that the decision allows a “design defect” claim against an FDA-approved prescription drug – and holds that the plaintiff doesn’t even have to prove an alternative design. Id. at *9-10. Ouch. That means that the plaintiff automatically gets to have the jury second-guess the FDA’s balancing of risks and benefits, something we think is bad law and worse policy. We blogged about this opinion here, and about the $21 million verdict that this pure risk/benefit theory later produced here. An appellate result in Bartlett thus has a significant chance of making our good or bad lists in 2011.

10. In re Levaquin Products Liability Litigation, 2010 WL 4882595 (D. Minn. Nov. 24, 2010). This is an absolutely terrible evidentiary ruling out of an MDL plagued with such rulings. Rule 407 says that subsequent remedial measures are inadmissible – period – to prove defect or negligence. But Levaquin ignores the plain language of the rule, which had already been amended once to dispose of a similar judge-made loophole, and holds that because FDA label changes are “mandatory,” the “policy” of the rule to encourage voluntary safety improvements isn’t applicable. 2010 WL 4882595, at *1. The decision adopted this view despite the ruling in Wyeth v. Levine, that label changes can be made voluntarily without FDA preapproval. For replacing the terms of Rule 407 with a whole-cloth “heads you lose, tails I win” exception admitting subsequent changes to FDA-approved labels, this decision takes the final spot on our list. We complained about it earlier, here.

Phew! Glad that’s over.

We even had to cut a few: Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (because Mensing (see 2009) got there first, and we’re not sure how we feel about generic preemption after Levine); Hunter v. Shire, Inc., 992 A.2d 891 (Pa. Super. 2010) (one of those terrible forum non conveniens decisions that contributed to Philly (we’d say rather unfairly) being named the #1 hellhole jurisdiction); and Tenuto v. Lederle Laboratories, 2010 WL 625223 (N.Y. Sup. Feb. 17, 2010) (defendant liable for not warning of a 1 in a million risk).

Don’t worry too much about us, though – we’ll be fine after a nice shower and a stiff drink. After all, from last years bottom ten, two of them (Nos. 4 (Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 485 & 517 (E.D. Pa. 2009)); and 10 (In re OxyContin II, 881 N.Y.S.2d 812 (N.Y. Sup. 2009)) have already been reversed, and a third (No. 6 (Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) just had certiorari granted by the Supreme Court.

Things will be better next week, we promise, when we present our list of the top ten best drug/device decisions of 2010.

About

This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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